Model Number K187 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker reverted to safety mode.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
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Event Description
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It was reported that this pacemaker reverted to safety mode.No adverse patient effects were reported.The device remains in service.Information does not indicate device replacement has yet been planned or undertaken at this time.If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that this pacemaker reverted to safety mode.No adverse patient effects were reported.The device remains in service.Information does not indicate device replacement has yet been planned or undertaken at this time.If pertinent information is provided in the future, a supplemental report will be submitted.It was reported that surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that bradycardia therapy remained available.The system resets occurred during other transient elevated power states and caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
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Event Description
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It was reported that this pacemaker reverted to safety mode.No adverse patient effects were reported.The device remains in service.Information does not indicate device replacement has yet been planned or undertaken at this time.If pertinent information is provided in the future, a supplemental report will be submitted.It was reported that surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.The product has been received for analysis.
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Search Alerts/Recalls
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